MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SIDEKICK SUPPORT CATHETER

Model Number	SD110TG
Medical Device Problem Codes	Retraction Problem (1536); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was returned to bd for evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model sd110tg support catheter experienced a retraction problem and material deformation.These reports were received from various sources.This event involved one patient with no patient consequences.The patient was a male who was 77 years old and weighed (b)(6).
Additional Manufacturer Narrative
For the reported event, lot number was provided, and lot history review.The device was returned for evaluation.One crosser catheter was stuck in the sheath.The tip of the sidekick was buckled and slightly bunched.The investigation is confirmed for material deformation and retraction problem.The root cause could not be determined based upon available information.The device was labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model sd110tg support catheter experienced a retraction problem and material deformation.These reports were received from various sources.This event involved one patient with no patient consequences.The patient was a male who was 77 years old and weighed 195 pounds.

• Brand Name: SIDEKICK SUPPORT CATHETER
• Common Device Name: SUPPORT CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8491974
• Report Number: 2020394-2019-00254
• Device Sequence Number: 13834118
• Product Code: DQY
• UDI-Device Identifier: 00801741124877
• UDI-Public: (01)00801741124877
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: SD110TG
• Device Catalogue Number: SD110TG
• Device Lot Number: GFBW0810
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 07/24/2019
• Patient Sequence Number: 1